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    Summary
    EudraCT Number:2021-000097-29
    Sponsor's Protocol Code Number:WA42985
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000097-29
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH ACTIVE CLASS III OR IV LUPUS NEPHRITIS, INCLUDING AN EVALUATION
    OF OPEN LABEL SAFETY AND PK IN A COHORT OF PEDIATRIC PATIENTS
    (AGED 5 to < 12)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Randomized Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients with Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label
    Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)
    A.4.1Sponsor's protocol code numberWA42985
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/050/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffman-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4047
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameObinutuzumab
    D.3.2Product code RO5072759
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Myfenax
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemycophenolate mofetil
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmycophenolate mofetil
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Nephritis (LN)
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). SLE is an autoimmune disease, in which the body’s immune system attacks its own healthy body tissue.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of obinutuzumab compared with placebo in
    adolescent participants (AP) with Class III/IV LN
    • To evaluate the safety of obinutuzumab and characterize the
    obinutuzumab PK profile in pediatric patients (PP) aged 5 to <12 with LN
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of obinutuzumab compared with placebo (AP)
    • To evaluate the safety of obinutuzumab compared with placebo (AP)
    • To characterize obinutuzumab pharmacokinetic (PK) profile (AP)
    • To characterize obinutuzumab pharmacodynamic (PD) profile
    • To evaluate changes in fatigue of participants treated with
    obinutuzumab compared with placebo (AP)
    • To evaluate change in SLE disease activity of participants treated with
    obinutuzumab compared with placebo (AP)
    • To evaluate changes in the quality of life of participants treated with
    obinutuzumab compared with placebo (AP)
    • To evaluate the efficacy of obinutuzumab (PP)
    • To evaluate the immune response to obinutuzumab
    • To evaluate potential effects of ADA
    • To evaluate autoantibodies over time (PP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants who are age 12 to <18 years at the time of randomization
    Participants who are age 5 to < 12 years (younger patient cohort) at
    the time of randomization once recruitment is open. (Investigators will
    be notified by the Sponsor when recruitment is open to this younger
    population)
    Ability to comply with the study protocol, in the investigator's judgment
    International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
    Positive current or historical test for antinuclear antibody (ANA) and/or antibodies to double-stranded DNA (dsDNA)
    Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
    Significant proteinuria defined by a urine protein-to-creatinine ratio (UPCR) above >0.5 g/g based on a first-morning void (FMV) collection at screening
    During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN
    For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 18 months after the final dose of obinutuzumab and for 6 weeks after the final dose of mycophenolate mofetil (MMF)
    For males: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, during the treatment period and for 90 days after the final dose of MMF
    E.4Principal exclusion criteria
    • Participants who are pregnant or breastfeeding, or intending to
    become pregnant during the study or within 18 months after the final
    dose of obinutuzumab or placebo, or within 6 weeks after the final dose
    of MMF
    • Severe, active central nervous system (CNS) SLE, including retinitis,
    poorly controlled seizure disorder, acute confusional state, myelitis,
    stroke, cerebellar ataxia, or dementia
    • Severe renal impairment, as indicated by glomerular filtration rate
    (GFR) within the past 6 months <30 mL/min/1.73m^2 (estimated using
    the modified Bedside Schwartz equationor or as indicated the need for
    renal transplant, plasmapheresis or dialysis at screening
    • Sclerosis in >50% of glomeruli on renal biopsy
    • Purely chronic Class III(c) or Class IV(c) disease on renal biopsy,
    defined as the absence of any active lesions
    • Presence of rapidly progressive glomerulonephritis
    • Pure Class V LN
    • Intolerance or contraindication to study therapies
    • Receipt of any of the following excluded therapies:
    – Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2
    months prior to screening or during screening
    – Any biologic B cell-depleting therapy (e.g., antiCD19, antiCD20,
    antiCD22) such as, but not limited to, rituximab, ocrelizumab, or
    ofatumumab within 9 months prior to the Day 1 baseline visit
    – Any biologic therapy (other than anti-CD19, anti-CD20, anti-CD22)
    such as, but not limited to, belimumab, daratumumab, ustekinumab,
    anifrolumab, secukinumab, or atacicept during the 2 months prior to
    screening or during screening
    – Oral inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine
    kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib,
    tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any
    investigational agent during the 2 months prior to screening or during
    screening
    – Any live vaccine during the 28 days prior to screening or during
    screening
    • Active infection of any kind (excluding fungal infection of nail beds) or
    any major episode of infection requiring hospitalization or treatment
    with IV anti-infective medications within 4 weeks prior to screening, or
    completion of oral anti-infectives within 2 weeks prior to randomization
    • History of or currently active primary or secondary immunodeficiency,
    including known history of HIV infection and other severe
    Immunodeficiency blood disorders
    • History of serious recurrent or chronic infection
    • History of progressive multifocal leukoencephalopathy (PML)
    • History of or current cancer, including solid tumors, hematological
    malignancies, and carcinoma in situ within the past 5 years
    • Major surgery requiring hospitalization during the 4 weeks prior to
    screening or during screening
    • High risk for clinically significant bleeding or any current condition
    requiring plasmapheresis, concomitant intravenous immunoglobulin use,
    or acute blood product transfusions
    • Significant or uncontrolled concomitant medical disease which, in the
    investigator's opinion, would preclude participant participation
    • Currently active alcohol or drug abuse or history of alcohol or drug
    abuse
    • Any of the following laboratory parameters at screening:
    - Aspartate aminotransferase (AST) or alanine transaminase (ALT)
    >2.5Xupper limit of normal (ULN) (for age and sex) that cannot be
    attributed to underlying SLE
    - Amylase or lipase >2XULN
    - Absolute neutrophil count (ANC) <1.5X10^3/microliter
    - Hemoglobin <8 g/dL, unless caused by autoimmune hemolytic anemia
    resulting from SLE
    - Platelet count < 110,000/μL for participants below age 12 and
    <50,000/microliter for participants age 12 or above
    - Positive hepatitis B surface antigen (HBsAg)
    - Positive hepatitis C serology
    - Positive serum human chorionic gonadotropin measured at screening
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of participants who achieve a complete renal response (CRR) at Week 76
    2. Incidence, nature, and severity of AEs, Incidence of laboratory or vital
    sign abnormalities from baseline to Week 76 analysis and serum
    concentrations of obinutuzumab at specified timepoints (PP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. At Week 76
    E.5.2Secondary end point(s)
    1. Proportion of adolescent participants achieving a CRR at Weeks 24
    and 52 (AP)
    2. Proportion of younger age participants achieving a CRR at Week 76
    (PP)
    3. Proportion of adolescent and younger age participants who achieve
    CRR with successful prednisone taper at Week 76
    4. Proportion of younger age participants achieving overall renal
    response (ORR) at Week 76 (PP)
    5. Proportion of adolescent participants who achieve a complete or
    partial renal response (PRR) at Week 76
    6. Proportion of adolescent participants achieving an overall response
    (CRR or PRR) at Weeks 24, 52, and 76 (AP)
    7. Change in urinary protein-to-creatinine ratio (UPCR) from baseline to
    Week 76 (AP)
    8. Change in estimated glomerular filtration rate (eGFR) from baseline
    to Week 76 (AP)
    9. Time to onset of CRR over the course of 76 weeks (AP)
    10. Proportion of participants who experience treatment failure from
    Week 12 to Week 76 (AP)
    11. Change in anti dsDNA titers from baseline to Week 76
    12. Change in C3 complement levels from baseline to Week 76 (AP)
    13. Change in C4 complement levels from baseline to Week 76 (AP)
    14. Incidence, nature, and severity of adverse events, with severity
    determined according to National Cancer Institute Common Terminology
    Criteria for Adverse Events (NCI CTCAE) from baseline to Week 76 (AP)
    15. Incidence of laboratory or vital sign abnormalities from baseline to
    Week 76 (AP)
    16. Serum concentrations of obinutuzumab at specified timepoints (AP)
    17. Proportion of participants achieving B-cell depletion, at specified
    timepoints
    18. Change in Pediatric Quality of Life Inventory-Multidimensional
    Fatigue scale (PedsQL)-Fatigue total score from baseline to Week 76
    (AP)
    19. Change in Systemic Lupus Erythematosus Disease Activity Index
    2000 (SLEDAI-2K) from baseline to Week 76 (AP)
    20. Change from baseline in Child Health Questionnaire-Parent Form 28
    (CHQ-PF28) domain scores from baseline to Week 76 (AP)
    21. Proportion of participants with anti-drug antibodies (ADA) at weeks
    0, 24, 52 and 76
    22. Relationship between ADA status and efficacy, safety,
    pharmacodynamic, or PK endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Weeks 24 and 52
    2-5. At Week 76
    6. At Weeks 24, 52, and 76
    7-9. Baseline to Week 76
    10. From Week 12 to Week 76
    11-15. Baseline to Week 76
    16. At Baseline and Weeks 2, 4, 12, 24, 26, 36, 52, 64, and 76
    17. At Baseline and Weeks 4, 24, 52 and 76
    18-20. Baseline to Week 76
    21. At Weeks 24, 52, and 76
    22. Up to approximately 3.5 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Peru
    Brazil
    Canada
    Russian Federation
    South Africa
    United Kingdom
    United States
    France
    Italy
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of this study is defined as the date when the LPLV occurs or the date at which
    the last data point required for statistical analysis of safety follow-up is
    received from the last participant, whichever occurs later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written informed consent for participation in the study must be obtained from a parent or guardian before performing any study-related procedures (including screening evaluations)."
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will offer continued access to Roche IMPs (obinutuzumab and MMF) free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined IN SECTION 6.6 of the protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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